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New treatment option for Acute Lymphoblastic Leukemia
Official title CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06777979
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- Collection and Manufacturing Eligibility
- Age \<21 years old
- Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as: \ CD19 and/or CD22-positivity confirmed within 2 months and after receipt...
- Second or greater relapse
- Any relapse after allogeneic HCT
You likely can't join if
- Known primary immunodeficiency
- Known HIV positivity
- Known contraindication to receiving protocol defined lymphodepleting
- chemotherapy regimen
- History of hypersensitivity reaction to murine protein-containing products Treatment Eligibility Inclusion Criteria:
- Age \< 21 years old
See the full eligibility criteria
- Collection and Manufacturing Eligibility
- Age \<21 years old
- Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as: \ CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
- Second or greater relapse
- Any relapse after allogeneic HCT
- Refractory disease (primary or in relapse) despite therapy designed to induce remission
- Estimated life expectancy of \> 12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
- For females of childbearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
- Known primary immunodeficiency
- Known HIV positivity
- Known contraindication to receiving protocol defined lymphodepleting
- chemotherapy regimen
- History of hypersensitivity reaction to murine protein-containing products Treatment Eligibility Inclusion Criteria:
- Age \< 21 years old
- Detectable disease in the bone marrow
- Estimated life expectancy of \> 8 weeks
- Karnofsky or Lansky (age-dependent) performance score \> 50 (Appendix A)
- Adequate cardiac function defined as left ventricular ejection fraction \>40%, or shortening fraction \> 25%
- EKG without evidence of clinically significant arrhythmia
- Adequate renal function defined as creatinine clearance or radioisotope GFR \>50 mL/min/1.73m2 (GFR \>40 mL/min/1.73m2 if \<2 years of age)
- Adequate pulmonary function defined as forced vital capacity (FVC) \>50% of predicted value; or pulse oximetry \>92% on room air
- Total bilirubin \< 3 times the upper limit of normal for age, except in people with Gilbert's syndrome
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5 times the upper limit of normal for age
- Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
- Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the...
- For females of childbearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
- If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom. Exclusion Criteria:
- Known primary immunodeficiency
- Known HIV positivity
- Known contraindication to receiving protocol defined lymphodepleting
- chemotherapy regimen
- History of hypersensitivity reactions to murine protein-containing products
- Severe, uncontrolled bacterial, viral or fungal infection
- Active CNS-3 disease
- Evidence of active, uncontrolled neurologic disease
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.